Valentus, Inc.

CLOSEOUT LETTER Valentus, Inc. MARCS-CMS 609611 — July 23, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Dietary Supplements Recipient: Recipient Name Dave Jordan Recipient Title Owner Valentus, Inc. 3900 W. 53rd Street Sioux Falls , SD 57106-4220 United States Issuing Office: Division of Human and Animal Food Operations West I United States (612) 334-4100 Dear Mr. Jordan: The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter dated November 30, 2020. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Carolyn A. Warren Compliance Officer, West Division 1 - CB Office of Human and Animal Foods Operations Content current as of: 07/30/2021 Regulated Product(s) Dietary Supplements